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Trial registered on ANZCTR


Registration number
ACTRN12619000358145
Ethics application status
Approved
Date submitted
22/02/2019
Date registered
6/03/2019
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dual-task training for falls prevention among community-dwelling elderly people in Hong Kong.
Scientific title
Physical and Cognitive Training (PACT) for fall prevention among community-dwelling elderly at the risk of falls in Hong Kong. A pilot randomized controlled trial with economic evaluation
Secondary ID [1] 297506 0
None
Universal Trial Number (UTN)
Trial acronym
PACT program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing 311698 0
Falls prevention 311699 0
Condition category
Condition code
Injuries and Accidents 310322 310322 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants of the PACT programme group will undergo the PACT programme with once-weekly 60-minute sessions for 12 weeks. The dosage of the intervention is in line with a previous study testing the benefits of dual-task training on walking among the elderly. The programme will combine cognitive tasks with physical activities. The intervention will be delivered as group therapy with no group exceeding five members. At the end of 12 weeks, participants will be provided with a booklet outlining the activities and will be encouraged to continue exercising at home over the follow-up period.
More information:
A booklet summarizing the exercises will be provided to all the participants of the experimental (PACT) group.
The procedure involved: PACT group participants will receive 10 minutes of warm up, 40 minutes of PACT training and 10 minutes of cool down exercises. PACT program includes performing four types of physical tasks during sit to stand, standing with feet apart, one leg, tandem standing, multidirectional reaching, stair climbing and walking (10 metres) tasks. The four cognitive tasks will include: counting backwards by subtracting 4 numbers (for mental tracking ), naming fruits, vegetables, or animals (for working memory), auditory cues for performing activities, example, perform heel raise when you hear the alphabet H (for improving attention and auditory discrimination), short story telling (for verbal fluency). In addition, falls prevention strategies will be taught.
Safety: Motor-cognitive interaction occurs with highly challenging cognitive tasks increasing the risk of falls among the elderly. Careful calibration of the difficulty level of the cognitive task is required to ensure the safety of the participants. The difficulty level and progression of the cognitive and physical task will be tailor-made according to the participants’ tolerance in order to ensure safety during practice.
Who will administer: A Hong Kong registered Physiotherapist will administer all the exercise.
(d) Strategies to monitor: Adherence to the intervention protocol will be monitored using electronic diaries to reduce missing values and recall errors (https://goo.gl/MsyrSo). At the end of the 12-week training, participants will be provided information on how to access and complete the electronic diaries.
We will use a digital diary designed for this study. A booklet summarising the list of exercises will be provided to all the PACT group participants for home practice. The booklet is specifically designed for this study.
Intervention code [1] 313748 0
Prevention
Comparator / control treatment
Usual care control group participants will continue the routine Hong Kong (HK) protocol for fall prevention. The intervention includes one group session (10 members) on fall prevention lasting for 60 minutes. Participants will be taught general stretching, strengthening exercises and strategies for fall prevention including home modification. Research Assistant 1 (RA1) will deliver the intervention. Participants will be encouraged to practice exercises at home. After 6-months follow-up the control group will receive two complementary sessions of PACT program.
Control group
Active

Outcomes
Primary outcome [1] 319207 0
Feasibility measures including adherence, acceptability, retention rate, and safety of proposed outcome measures
Adherence: is the number of sessions attended against the number of sessions prescribed. Attendance will be estimated in percentage.
Acceptability: A qualitative interview will be conducted at the end of the training session. During the interveiew, the participants will be enquired about the ease of exercises, positives and negatives of the exercise program.
Retention rate: Will be estimated as the number of participants available at the end of the intervention and follow-up.
Safety: Will be reported as the number of adverse events such as falls within the intervention period.
Timepoint [1] 319207 0
Post-intervention (12 weeks after intervention)
Secondary outcome [1] 367302 0
Dual-task cost of balance using the Timed up and go test
Timepoint [1] 367302 0
Baseline, post-intervention (12 weeks after intervention) and 6 months follow-up assessment
Secondary outcome [2] 367303 0
Falls history: The number of falls will be assessed using the self-reported falls diary completed by the participant during the trial period.
The number of falls over the past 3 months will be recorded as a baseline estimate of falls history.
Timepoint [2] 367303 0
Baseline, post-intervention and 6 months follow-up assessment
Secondary outcome [3] 367306 0
Montreal Cognitive Assessment
Timepoint [3] 367306 0
Baseline, post-intervention and 6 months follow-up assessment
Secondary outcome [4] 367307 0
Falls Efficacy Scale- International
Timepoint [4] 367307 0
Baseline, post-intervention and 6 months follow-up assessment
Secondary outcome [5] 367308 0
EuroQol-5 dimension 5 level
Timepoint [5] 367308 0
Baseline, post-intervention and 6 months follow-up assessment

Eligibility
Key inclusion criteria
(1) Males and females aged 60 and over,
(2) Community-dwelling
(3) Ambulant with or without the use of a walking assistive device
(4) Must have had at least 1 fall over the past 6 months
(4) Berg Balance Scale (BBS) score of less than or equal to 45 indicating the individual at the risk of falls
(5) Obtain a mini-mental state examination score of 24 indicating the absence of cognitive impairment
Minimum age
60 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Diagnosed with dementia or Alzheimer’s disease,
(2) Previous history of psychiatric illness,
(3) Only able to walk with hand-held support and
(4) Severe visual impairment preventing exercise participation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An administrator who is not a part of the research team will randomise participants to one of the intervention groups using pre-determined block randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random number list will be created by the statistician (CC: co-investigator), and each participant will receive a unique identification number. The group allocation will not be revealed to the PI in order to ensure treatment allocation concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The nature of the intervention is such that participant and trainer (RA1) cannot be blinded. However, SW and CC will conduct the analysis blinded. Appointments for intervention sessions will be made by RA1 to ensure assessor blinding. All participants will be assessed following the assessment schedule by RA2 who will be blinded to group allocation. Appendix-3 outlines the flow of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic data will be reported as mean and standard deviation for continuous variables and number and percentage for categorical variables. Primary outcomes will be analysed at the end of 12 weeks, and the secondary outcomes will be analysed throughout the follow-up period. Mean baseline scores between the groups will be compared using independent t-tests. Analysis of covariance (ANCOVA) will be used to compare the clinical outcome measures at the 95% confidence interval. ANCOVA has the advantage of comparing clinical outcome measures with a significant difference in baseline values. Furthermore, it improves the statistical power and accuracy even when the baseline differences are small and insignificant.
The cost-effectiveness analysis will be performed according to the intention-to-treat principle. Maximum likelihood imputation will be used to generate data for missing items. Anticipating a highly skewed distribution of the cost data, bootstrapping with 5000 replications will be used to establish ‘approximate bootstrap confidence (ABC)’ intervals across the cost variability. The EQ-5D-5L will be used to estimate the QALY gain or loss over the follow-up period. The mean QALY gain or loss will be calculated for each group at six months post-intervention. In addition, the mean incremental QALY gain will be estimated for the intervention groups. The incremental cost-effectiveness ratio (ICER) will be calculated using the mean incremental cost and mean incremental effect by substituting with the formula:
ICER = Difference in C / Difference in E
where E is the gain in QALY and C is the cost.
The cost-effectiveness of the intervention groups will be geographically represented using the cost-effectiveness plane (CE). Finally, the threshold for cost-effectiveness or the amount of money the country is willing to pay to gain one unit of effect (QALY) will be calculated. The cost-effectiveness acceptability curve (CEAC) will be derived based on the threshold value. Using the CEAC, the cost-effective treatment option will be predicted based on the different threshold levels.
Sensitivity analysis: In order to enhance the robustness of the cost-effectiveness analysis the following two sensitivity analysis will be performed
(1) Analyses will be repeated with complete cases alone, and
(2) by excluding cost outliers or data from participants with extremely high costs, such as multiple surgeries or extended hospital stays.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2019
Actual
Date of last participant enrolment
Anticipated
31/07/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 21303 0
Hong Kong
State/province [1] 21303 0
Hung Hom

Funding & Sponsors
Funding source category [1] 302065 0
University
Name [1] 302065 0
Faculty Collaborative Research Scheme between Social Sciences and Health Sciences, The Hong Kong Polytechnic University
Country [1] 302065 0
Hong Kong
Primary sponsor type
University
Name
Faculty of Health and Social Sciences, Deans reserve, The Hong Kong Polytechnic University
Address
1, Yuk Choi Road, The Hong Kong Polytechnic University, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 301880 0
None
Name [1] 301880 0
Address [1] 301880 0
Country [1] 301880 0
Other collaborator category [1] 280563 0
University
Name [1] 280563 0
Dr Bai Xue
Address [1] 280563 0
1, Yuk Choi Road, The Hong Kong Polytechnic University, Hong Kong
Country [1] 280563 0
Hong Kong
Other collaborator category [2] 280564 0
University
Name [2] 280564 0
Dr William Tsang
Address [2] 280564 0
1, Yuk Choi Road, The Hong Kong Polytechnic University, Hong Kong
Country [2] 280564 0
Hong Kong
Other collaborator category [3] 280565 0
University
Name [3] 280565 0
Dr Wai-chi Chan
Address [3] 280565 0
Clinical Associate Professor
Honorary Consultant Psychiatrist & Head of Psychogeriatric Service,
102 Pokfulam Road, Hong Kong, Queen Mary Hospital, Hong Kong. Phone: (852) 22554486
Country [3] 280565 0
Hong Kong
Other collaborator category [4] 280566 0
University
Name [4] 280566 0
Dr Cynthia Chen
Address [4] 280566 0
Saw Swee Hock School of Public Health, National University of Singapore
Tahir Foundation Building
National University of Singapore
12 Science Drive 2
#10-01
Singapore 117549
Country [4] 280566 0
Singapore
Other collaborator category [5] 280567 0
University
Name [5] 280567 0
Professor Susan Whitney
Address [5] 280567 0
School of Health and Rehabilitation Sciences, University of Pittsburgh
Bridgeside Point 1
100 Technology Drive, Suite 210

Pittsburgh, PA 15219
412-383-6642
Country [5] 280567 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302746 0
Human subject ethics application review system
Ethics committee address [1] 302746 0
Ethics committee country [1] 302746 0
Hong Kong
Date submitted for ethics approval [1] 302746 0
20/11/2018
Approval date [1] 302746 0
04/12/2018
Ethics approval number [1] 302746 0
HSEARS20181217001

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91254 0
A/Prof Stanley J Winser
Address 91254 0
Suite 514, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Country 91254 0
Hong Kong
Phone 91254 0
+85227666746
Fax 91254 0
Email 91254 0
stanley.j.winser@polyu.edu.hk
Contact person for public queries
Name 91255 0
Stanley J Winser
Address 91255 0
Suite 514, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Country 91255 0
Hong Kong
Phone 91255 0
+85227666746
Fax 91255 0
Email 91255 0
stanley.j.winser@polyu.edu.hk
Contact person for scientific queries
Name 91256 0
Stanley J Winser
Address 91256 0
Suite 514, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Country 91256 0
Hong Kong
Phone 91256 0
+85227666746
Fax 91256 0
Email 91256 0
stanley.j.winser@polyu.edu.hk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1440Ethical approval    377049-(Uploaded-22-02-2019-16-17-36)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.